Medicare unveils coverage criteria for Dexcom G5 continuous glucose monitor

dexcom g5 system including cell phone and app
While the CMS criteria cover all therapeutic continuous glucose monitoring systems, Dexcom's G5 Mobile System is the only device approved as a therapeutic CGM. (Dexcom)

The Centers for Medicare & Medicaid Services published criteria for coverage of therapeutic continuous glucose monitoring systems. Type 1 and Type 2 diabetes patients covered by Medicare who are on intensive insulin therapy may now get reimbursed for their Dexcom G5 CGM.

While several CGMs are on the market, including systems from Medtronic and Abbott, Dexcom’s G5 Mobile system is the only CGM classified as “therapeutic.” A therapeutic CGM is used to inform treatment decisions. Most CGMs are FDA-approved as adjunctive devices, meaning the information they provide is to be used alongside data from other devices, such as blood glucose monitors.

CGMs include a sensor, inserted just under the skin, which measures glucose levels in the interstitial fluid. A transmitter then sends glucose data wirelessly to a receiver and/or a mobile device, where a patient may see a graph showing their glucose trends over time.

The CMS criteria are that the patient must have diabetes, use a home blood glucose monitor to test for glucose levels frequently, be treated with multiple daily injections of insulin or with an insulin pump, and need to frequently adjust his or her insulin therapy based on data from a therapeutic CGM.

“This is a new era and a huge win for people with diabetes on Medicare who can benefit from therapeutic CGM,” said Dexcom CEO Kevin Sayer in a statement. “This decision supports the emerging consensus that CGM is the standard of care for any patient on intensive insulin therapy, regardless of age.”

The publication of criteria follows a CMS ruling in January that designated therapeutic CGMs as durable medical equipment under Medicare Part B. The ruling allowed Medicare to cover therapeutic CGMs on a case-by-case basis.